BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COZMO INSULIN PUMP

    MDR report key: 1081287 · Received July 22, 2008

    Report

    Report Number
    2183502-2008-00205
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 22, 2008
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT REPORTED A PT WAS HOSPITALIZED IN 2008 DUE TO AN INCIDENT OF HYPOGLYCEMIA. THE REPORTER STATED THAT HIS BLOOD GLUCOSE HAD BEEN VERY LABILE FOR 3 TO 4 WEEKS. HE REPORTS THAT HE HAD BEEN WORKING WITH HIS PHYSICIAN TRYING TO ADJUST HIS RATES IN AN ATTEMPT TO GAIN BETTER CONTROL OF HIS BLOOD GLUCOSE LEVELS. THE EVENING BEFORE HIS HOSPITALIZATION, HIS BLOOD GLUCOSE WAS IN THE 60'S AT 11:30 PM. HE ATE THEN RE-TESTED 15 MINUTES LATER WITH NO CHANGE IN BLOOD GLUCOSE. HE ATE AGAIN AND TESTED, HIS BLOOD GLUCOSE WAS UP TO 100 MG/DL. HE WENT TO BED AND AN HOUR LATER WAS FOUND UNRESPONSIVE. HE WAS TRANSPORTED TO THE HOSPITAL WHERE HE WAS TREATED AND RELEASED. THE DEVICE WILL BE RETURNED FOR EVAL; TO ENSURE THAT IT IS FUNCTIONING CORRECTLY AND DID NOT CONTRIBUTE TO THE REPORTED INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COZMO INSULIN PUMP INSULIN PUMP LZG SMITHS MEDICAL MD (FORMERLY DELTEC, INC.) 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization